Given the high risk of virus contamination of these products, stringent controls are needed for sourcing the starting materials from donors. Further, orthogonal steps in the manufacturing process must be validated for effective virus and prion removal or inactivation.
ViruSure provides expert support to manufacturers of such products both via risk assessments as well as the performance of virus and prion clearances studies to confirm the reduction capacity of the purification process.
ViruSure offers the following services
for producers of plasma/urine-derived proteins:
In Vivo Potency Studies